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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter FPart 607Subpart A → §607.1


Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
Subpart A—General Provisions


§607.1   Scope.

(a) This part establishes establishment registration and product listing requirements for manufacturers of human blood and blood products.

(b) This part establishes establishment registration and product listing requirements for manufacturers of products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act and that are licensed under section 351 of the Public Health Service Act, as well as licensed biological products used in the manufacture of a licensed device.

[81 FR 60221, Aug. 31, 2016]

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